Thursday, March 7, 2013

Resistance is Increasing!

Surprise!  The big news this week is that antibiotic resistance is getting worse here in the US.  The CDC has been following carbapenem-resistance in Enterobacteriaeceae over the last decade.  Do they do this in a systematic and prospective way covering all of the US?  Is this a reportable infection?  No and no.  The data they show is still disturbing.  Among Klebsiella, carbapenem resistance has gone from 1.6 to 10.4% in the National Nosocomial Infection Surveillance data and from 0 to 5.3% in the Eurofins TSN microbiology surveillance network over the last decade.  The data only go up to 2011 – so expect 2012 to be even worse. The CDC data does not address carbapenem resistance in other important Gram negative pathogens like Pseudomonas and Acinetobacter. 

It is time for the CDC to start easing off on MRSA surveillance and to start working on Gram negative resistance – especially resistance to our last line of antibiotics for Gram negatives, the carbapenems.  Many of these strains are either completely untreatable or are only susceptible to antibiotics that have not demonstrated efficacy in very serious infections like hospital acquired pneumonia caused by these strains (tigecycline and colistin).  Based on data from 2007, about 63,000 Americans suffered such highly resistant infections in hospitals every year.  That number has certainly increased and may have even doubled since then.

One might cynically ask why the CDC is publicizing these data at this moment in time.  Is it related to funding concerns with the sequester looming?  If so – more power to them – but they need to focus on the emerging resistance issues and public health threats of today.  And – we need prospective active and ongoing surveillance to get accurate population-based incidence rates for these resistant infections.

At the same time, the FDA seems to be trying to reboot.  This reboot is absolutely required for us to have the robust pipeline of new antibiotics we need to combat these resistant infections.  As noted in the last blog, the FDA has been involved in a number of fora recently including a public hearing on the LPAD pathway for rapidly getting new antibiotics active against these highly resistant pathogens to patients who desperately need them.   But they have also stopped following their own guidance on more traditional antibiotic development pathways.  In this regard, I pointed out at the last Brookings meeting that the FDA MUST go public.  Either the guidance documents must be revised to reflect the actual guidance they are currently providing to sponsors (this will take a long time) or they need to publicly note which areas of guidance they are no longer following.  They are allergic to “guidance by pulpit” – but they have to do something to get their current thinking out to the public.

As you faithful readers would have seen from my blog Calling All Large PhRMA back in December of last year, I invited a number of companies who had abandoned antibiotic R&D to get back in.  I believe that Roche-Genentech is dipping their toes in the water with a new deal with RQx to discover new antibiotics active against bacterial signal peptidase.  Whether this can be called a victory for the pro-antibiotics effort or not is hard to tell.  Lots of companies have already broken their teeth at least once on this target – but maybe RQx-Genentech have something special going on.  

In addition to the blog, I wrote several companies.  I had a response from one – who said no thanks.  I know that that particular company is well versed in what is going on in terms of the new regulatory environment and potential for new pricing models for antibiotics – so their decision seems to have been deliberate and strategic for them.  But for the rest – no response. Is this because they have given this possibility careful and informed consideration and decided not to go forward or is it because they no longer have the internal expertise to even think about getting back into antibiotic R&D?  Is it because they couldn’t care less?  I have no idea. 

But the FDA going public might help encourage companies to get back in.  So – FDA – back to you!

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